The Center for International Environmental Law (CIEL), ClientEarth, and Friends of the Earth Germany (BUND) released on November 13, 2012, a proposal for European Union (EU) legislation to address the risks of nanomaterials. CIEL states that the non-governmental organizations’ (NGO) proposal was prompted by the European Commission’s (EC) October 3, 2012, Communication on the Second Regulatory Review on Nanomaterials. The Communication describes the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program as “the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures” and notes that “more specific requirements for nanomaterials within the framework have proven necessary.” The NGOs maintain that further regulatory action is necessary, and recommend a “nano patch” for REACH, including an obligation for all nanomaterials to be considered distinct from their non-nanoscale counterparts and substantially lower volume thresholds for registration of nanoscale substances. The NGOs also call for an EU-wide registry for all nanomaterials and products on the market.

The EC’s Environment and Enterprise Directorate-Generals (DG) issued separate statements in response to the NGOs’ proposal. DG Environment stated: “We regard the NGO proposal . . . as a reaction to the Commission’s recent regulatory review on nanomaterials. We are looking forward to discussing our review with all the stakeholders.” DG Enterprise released a more detailed statement, noting that the EC “does not consider appropriate at present to change the basic registration rules under REACH and the rules for when a chemical safety assessment is required under REACH.” In addition, DG Enterprise stated: “[T]he highest volume substances such as carbon black and synthetic amorphous silica, as well as the most debated substances such as titanium dioxide, zinc oxide and carbon nanotubes, have already been registered under REACH. Together, they represent the vast majority of nanomaterials on the market in terms of tonnage and sales value.”

On October 3, 2012, the European Commission (EC) announced its adoption of a Communication on the Second Regulatory Review on Nanomaterials, which assesses the adequacy and implementation of European Union (EU) legislation for nanomaterials, indicates follow-up actions, and responds to issues raised by the European Parliament (EP), EU Council, and the European Economic and Social Committee. The Communication concludes that “nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not.” Since possible risks are related to specific nanomaterials and specific uses, nanomaterials should be assessed on a case-by-case basis. The Communication states: “Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required.” According to the Communication, the EC “remains convinced that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures but more specific requirements for nanomaterials within the framework have proven necessary. The Commission envisages modifications in some of the REACH Annexes and encourages ECHA to further develop guidance for registrations after 2013.” To improve the availability of information, the EC states that it “will create a web platform with references to all relevant information sources, including registries on a national or sector level, where they exist. In parallel, the Commission will launch an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight, including an in-depth analysis of the data gathering needs for such purpose. This analysis will include those nanomaterials currently falling outside existing notification, registration or authorisation schemes.”

The Communication is accompanied by an EC Staff Working Paper on Types and Uses of Nanomaterials, Including Safety Aspects, which responds to the EP’s concern that the EC’s approach to nanomaterials is jeopardized by a lack of information on the use and safety of nanomaterials that are already on the market. The Staff Working Paper provides detailed information on the definition of nanomaterials, nanomaterial markets, uses, benefits, health and safety aspects, risk assessment, and information and databases on nanomaterials. According to the Staff Working Paper, in response to the EP’s call on the EC to compile a public inventory of the different types and uses of nanomaterials on the European market, the EC has compiled information on existing databases and intends to create an EC web platform on nanomaterial types and uses, including safety aspects.

REACH does not define nanomaterials, and contains no nano-specific provisions;

Most nanomaterials evade registration until 2018, yet they can still enter the European Union (EU) market;

REACH’s schedule for registration hinges on the number of tonnes of a chemical, essentially missing all nanomaterials, which are generally produced in far smaller quantities; and

REACH test guidelines fail to consider the special properties of nanomaterials.

CIEL proposes stand-alone regulation, aligned with REACH, but specifically tailored to nanomaterials. CIEL states that such a regulation “would establish clear, legally binding provisions for nanomaterials and create a transparent and predictable legal environment for the safe production and use of nanomaterials in the EU.”

The European Parliament (EP) passed a resolution on December 15, 2011, stating that nanomaterials must be covered by current European Union (EU) health and safety rules, based on a mid-term review of the EU’s 2007-2012 health and safety at work strategy. The resolution, which was adopted with 371 votes in favor, 47 against, and 15 abstentions, also calls for the assessment of the effects of new technologies on health. The EP calls for legislation to ensure that nanomaterials are covered by the current European Occupational Health and Safety regulation.

On November 23, 2011, the European Union (EU) Council’s committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for “problematic” substances. The proposed legislation states that there is “scientific uncertainty” about the safety of nanomaterials, and “to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials, if possible based on the work of appropriate international fora, and to specify that the approval of an active substance does not include the nanomaterial form unless explicitly mentioned.” The proposed legislation calls on the European Commission (EC) to “regularly review the provisions on nanomaterials in the light of scientific progress.”

The proposed legislation incorporates the EC’s recent recommendation on the definition of a nanomaterial, stating:

“nanomaterial” means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm;

Fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.

For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:

The EC would have the authority to determine, at the request of a member state, whether a substance is a nanomaterial. It would also have the authority to adopt delegated acts to adapt the definition of nanomaterial “in view of technical and scientific progress and taking into account the Commission Recommendation.” Under the proposed legislation, where nanomaterials are used in a product, the risk to the environment and to health must be assessed separately. Labels would be required to include the name of all nanomaterials contained in biocidal products, followed by the word “nano” in brackets. Every five years, member states would be required to submit to the EC a report on the implementation of the biocides regulation in their respective territories. The report must address several topics, including information on the use of nanomaterials in biocidal products and the potential risks.

Both the EU Council and the EP must approve the proposed legislation. The EP is scheduled to vote on the proposed legislation in January 2012.

The Nanotechnology Industries Association (NIA) will hold a workshop on November 30, 2011, entitled “Defining Nano!? Compliance Requirements & Market Impact of the EU Definition of ‘Nanomaterials.’” The workshop, which will be held in Brussels, Belgium, is intended to answer questions such as which market sectors will be affected by additional regulatory compliance, the economic impact on current and future applications of nanotechnologies, how the European Union (EU) definition will be implemented in European legislation and in EU member states, and what companies can do in the short-term to offset the cost of long-term compliance.

The European Commission (EC) adopted on October 18, 2011, a Recommendation on the definition of a nanomaterial. The Recommendation “invites” member states, European Union agencies, and economic operators to use the following definition of nanomaterial “in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies”:

2. “Nanomaterial” means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm.

In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.

3. By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.

The Recommendation states that, by December 2014, the EC will review the definition “in the light of experience and of scientific and technological developments. The review should particularly focus on whether the number size distribution threshold of 50 % should be increased or decreased.”

According to information on the EC website, it will use the definition primarily to identify materials for which special provisions might apply (e.g., for risk assessment or ingredient labeling). The EC notes:

Nanomaterials are not intrinsically hazardous per se but there may be a need to take into account specific considerations in their risk assessment. Therefore one purpose of the definition is to provide clear and unambiguous criteria to identify materials for which such considerations apply. It is only the results of the risk assessment that will determine whether the nanomaterial is hazardous and whether or not further action is justified.

The National Nanotechnology Initiative (NNI) has posted the presentations from the March 10-11, 2011, workshop entitled “US-EU: Bridging NanoEHS Research Efforts,” which was intended to continue the robust dialogue between the U.S. and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives. The workshop covered the following areas:

Hands-on participation in joint programs of work that will better leverage resources; and

Development of communities of practice areas, including identification of key points of contact, interest groups, themes between key U.S. and EU researchers, and key U.S. and EU funding sources for near-term and future collaborations.

The European Commission (EC) announced on July 13, 2011, that European Union (EU)-funded scientists have developed risk assessment criteria for engineered nanomaterials “that will help support experts in making innovation and policy decisions.” According to the EC, findings reveal that product design can affect the unintentional release of engineered nanomaterials. The scientists suggest that the risk assessment criteria should be used to assess and minimize potential risks, which the EC states “would benefit those working in the building sector in particular, because it is estimated that nanomaterials will be used to develop 15% to 30% of facade coatings within the next 4 years.” The study is presented in the journal Environment International.

The recast of the Directive on the Restriction of Hazardous Substances (RoHS) was published in the July 1, 2011, Official Journal of the European Union. The notice calls for the restriction of other hazardous substances and their substitution by more “environmentally friendly alternatives” as soon as scientific evidence is available, and taking into account the precautionary principle. The notice specifically states that these “other hazardous substances” include “any substances of very small size or with a very small internal or surface structure (nanomaterials) which may be hazardous due to properties relating to their size or structure.” Proposed restrictions on additional substances, including nanosilver and long multi-walled carbon nanotubes, were not supported by the European Union (EU) Council and were not included in the version of the legislation passed by both the EU Council and European Parliament (EP).

The Netherlands delegation submitted a paper entitled “Risks associated with nanomaterials” for discussion during the June 21, 2011, meeting of the Environment Council of the European Union (EU). The paper states that, under current EU legislation and the precautionary principle, “industry bears primary responsibility for the safety of its products for workers and consumers.” The current legislation is intended, however, “to assess the hazards of chemical substances used in products, such as cosmetics, but is not geared to evaluating the specific hazards related to nanoengineered particles.” According to the delegation, a key problem is the lack of a generally accepted definition of what constitutes a nanomaterial. The paper calls on the European Commission (EC) to take three steps to regulate nanomaterials: (1) reach agreement on a broadly applicable definition of nanomaterials that covers as many materials with nanospecific risks as possible; (2) ensure traceability and enable a fast and adequate response should a specific nanomaterial ever be found to be hazardous; and (3) develop an adequate risk assessment system for nanomaterials and for products with nanoscale features, and, where necessary, of risk control measures. The paper urges the EU to take action, rather than member states, to prevent industry from facing non-harmonized definitions of nanomaterials, different substance databases, additional administrative costs, and possible market restrictions for certain materials or products. The paper notes that, in the absence of such measures, however, member state initiatives “may be necessary to protect health and the environment.”

The Silver Nanotechnology Working Group (SNWG) prepared a May 2, 2011, statement regarding the German Federal Institute for Risk Assessment's (BfR) April 12, 2011, statement concerning consumer products containing nanosilver. SNWG notes that, in December 2009, BfR published an opinion advising against the use of nanosilver in consumer products. Industry and other groups, including SNWG, asked BfR to reconsider its position, and BfR held a workshop on February 17, 2011, on nanosilver. SNWG states that, despite BfR’s assurance that follow-up dialogue would occur after the workshop, BfR instead issued its April 12, 2011, statement, which restated BfR’s initial opinion. According to SNWG, BfR has “essentially ignore[d] the facts presented to BfR during the workshop.” SNWG reviews BfR’s concerns regarding nanosilver -- the use of silver aims to replace normal hygiene measures, the potential for bacterial resistance from silver, and claims of unusual effects of nanosilver -- and addresses each. SNWG highlights the benefits to consumers from antimicrobial products, including longer shelf-life and protection from the degrading action and colonization of bacteria. SNWG notes that BfR disregarded multiple references regarding the low risk of resistance to silver and wrongly singled out nanosilver to address a concern about silver resistance in general. Finally, SNWG rebuts BfR’s assumptions concerning the use of silver and nanosilver, and concludes that the “mode of action is therefore not unusual in comparison to other silver forms employed in the marketplace or used throughout history.” SNWG describes additional issues of concern regarding BfR’s position on nanosilver, including its misunderstanding of materials and history; the selective harm to small- and medium-sized enterprises; and its preemption of the European Union regulatory process.

In an important and little noticed May 3, 2011, Federal Register notice, the U.S. Department of Commerce (DOC) International Trade Administration (ITA) requested public comments concerning regulatory cooperation between the U.S. and the European Union (EU) that would help eliminate or reduce unnecessary divergences in regulation and in standards used in regulation that impede U.S. exports. Of critical importance, the ITA plainly recognizes and acknowledges that the main impediments to greater trade and investment between the U.S. and EU “are not tariffs or quotas, but rather differences in regulatory measures.” The ITA seeks public input to help identify divergences in regulatory measures in the transatlantic marketplace, “so that the U.S. Government can work cooperatively with the European Union to address them.” This notice offers an important opportunity to educate the ITA on subtle, yet significant trade impacts that are derivative of regulatory and/or competitive issues. ITA also seeks recommendations for existing or emerging industry or product sectors that may benefit from regulatory cooperation between the U.S. and the EU. ITA asks that submitters be as specific as possible in describing the relevant product or product sector in which they believe there is an opportunity to facilitate trade without undermining U.S. public health, safety, environmental, and other legitimate policy objectives. ITA states that it is interested in receiving recommendations concerning any product sector that, due to the volume of trade between the U.S. and EU, “is a justifiable focus of enhanced regulatory cooperation.” Comments are due June 2, 2011.

The European Parliament (EP) and European Union (EU) Council failed to reach agreement on an update to the novel foods regulation, which would have updated the 1997 regulation to address several issues, including nanoscale ingredients in food. According to a March 29, 2011, press release, the EP and Council disagreed on labeling food from cloned animals and their descendents, as well as nanotechnology. The draft legislation passed by the EP in July 2010 would have banned nanoscale ingredients from food until the risks posed are better understood, and would have required that any nanoscale ingredients eventually authorized be clearly labeled as such. The EP issued a March 29, 2011, statement, which notes that the failure to reach an agreement on the legislation means “[t]here will continue to be no special measures regarding nanomaterials in food, for example.”

According to a March 10, 2011, press release, the risks connected with nanomaterials are one of the areas on which the Swedish Chemicals Agency (KemI) will focus in its national action plan, which will apply from 2011-2014. The press release states that the objective is for Sweden “to become one of the leading member states in the [European Union (EU)] in proposing new bans and restrictions.” Sweden expects the action plan to “lead to intensified cooperation and dialogue with other government agencies, industry, researchers, environmental and consumer organisations.” In December 2010, the Swedish government commissioned KemI to produce a “national action plan for a toxin-free everyday environment.” KemI intends to focus on children “as they are more vulnerable to the influence of chemicals.” KemI will examine EU legislation and work to strengthen it to limit the presence of hazardous chemicals in products. KemI states that companies that manufacture and import products “should to a larger extent substitute hazardous chemicals, and they will be supported in these efforts.” KemI intends to expand enforcement activities in the form of inspection of articles.

On February 11, 2011, the European Union (EU) Regulatory Committee voted to adopt revised environmental criteria for hand dishwashing detergents and all-purpose cleaners and cleaners for sanitary facilities. The Committee supported a European Commission (EC) proposal not to exclude nanomaterials from products awarded the voluntary EU ecolabel, despite concerns from members states, including Austria, Germany, France, Denmark, Slovakia, and Poland, as well as Norway. The EC proposed that the definition of nanomaterials should be established before a ban is introduced. According to the adopted text, “nanoforms” should comply with the existing criteria on hazardous substances.

On November 24, 2010, the European Parliament (EP) overwhelmingly approved the proposed recast of the Restriction of Hazardous Substances (RoHS) Directive, which restricts the use of certain hazardous substances in electronic and electrical equipment (EEE). The EP passed by a vote of 640 to 3, with 12 abstentions, legislation that would extend the Directive to most EEE, unless specifically excluded. The legislation calls for a review of the Directive after three years, at which time new substances may be added. Exemptions for banned substances would be allowed only if they are in the interest of consumer health and safety and no alternatives are available. Proposed restrictions on additional substances, including nanosilver and long multi-walled carbon nanotubes, were not supported by the European Union (EU) Council and are not included in the version of the legislation passed by both the EU Council and EP. The EP press release notes that “nanomaterials are cited as due for further scientific scrutiny” when RoHS is reviewed in three years.

On October 21, 2010, the European Commission (EC) began a consultation on its proposal for a definition of the term “nanomaterial” that the it intends to use as “an overarching, broadly applicable reference term” for any European Union (EU) communication or legislation addressing nanomaterials. The EC states that the definition of the term “nanomaterial” should be based on available scientific knowledge and should be used for regulatory purposes. The definition should determine when a material should be considered as a nanomaterial for legislative and policy purposes in the EU. The EC proposes to define as a nanomaterial any material meeting at least one of the following criteria:

Consists of particles, with one or more external dimensions in the size range 1 nanometer (nm)-100 nm for more than one percent of their number size distribution;

Has internal or surface structures in one or more dimensions in the size range 1 nm-100 nm; or

Has a specific surface area by volume greater than 60 m2/cm3, excluding materials consisting of particles with a size lower than 1 nm.

The EC states that it intends to carry out a public consultation by 2012 and, if appropriate, review the adequacy of the definition “taking into account experience gained, scientific knowledge and the technological development.”

During a September 14, 2010, conference on nanomaterials management, Paul Magnette, the Belgian Minister for Energy, Environment, Sustainable Development, and Consumer Protection, proposed to create a specific register for nanomaterials under the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) program and to implement mandatory labeling for nanomaterials used in consumer products. According to Magnette, the next European Environment and Health Action Plan is expected to address the challenge of nanomaterials among its priority areas. In 2011, the European Commission (EC) must also respond to the April 2009 European Parliament (EP) resolution on the regulatory aspects of nanomaterials. The resolution calls for various “ambitious” measures to ensure safety with regard to nanomaterials and nanotechnology. Magnette put forward five proposals from the Belgian Presidency of the European Union (EU) that are intended to respond to consumer needs while ensuring their safety:

Define the obligation to inform the consumer of the presence of nanomaterials in consumer products;

Ensure the traceability of the chain so as to be able to return to the source, if necessary. Regarding this aspect, it would be obligatory to maintain a register of nanomaterials;

Identify the most appropriate regulatory path at the EU level for risk evaluation and management;

Encourage member states, during this transitory period, to take up the responsibility and draw up integrated national strategies and concrete measures in favor of risk management, information, and monitoring; and

Regulate the claims made on labels of products containing nanomaterials.

On July 12, 2010, the European Commission (EC) opened a public consultation on the pre-consultation opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) entitled “Scientific Basis for the Definition of the Term ‘Nanomaterial.’” The EC states that its services need a working definition for the term “nanomaterial” to ensure the consistency of forthcoming regulatory developments, to guide the effective implementation of existing regulations, and to contribute to international work and dialogue on nanotechnology definitions. In its opinion, SCENIHR notes that the commonly used definition of the nanoscale is having a size between approximately 1 and 100 nanometers (nm). SCENIHR states, however, that there is no scientific evidence in favor of a single upper limit, and that there is no scientific evidence to qualify the appropriateness of the 100 nm value. According to SCENIHR, there is a need for a more elaborate description to identify unequivocally a nanomaterial or a product containing a nanomaterial for various European Union (EU) regulatory bodies. In its opinion, SCENIHR provides advice on the essential scientific elements of a working definition for the term “nanomaterial” for regulatory purposes, and discusses existing definitions formulated by various bodies. SCENIHR proposes to define an enforceable definition of “nanomaterial” for regulatory use by setting an upper limit for nanomaterial size, and adding to the proposed limit additional guidance (requirements) specific for the intended regulation. SCENIHR states:

Crucial in the guidance that needs to be provided is the extended description of the nanoscale. Merely defining single upper and lower cut-off limits is not sufficient in view of the size distributions occurring in manufactured nanomaterials. Although many nanomaterials are produced for specific properties at the nanoscale, at the moment it is not possible to identify a specific size or a specific generic property that is suddenly introduced or changed with size. Alternatively, a tiered approach may be required depending on the amount of information known for any specifically engineered nanomaterial and its proposed use.

On July 7, 2010, the European Parliament (EP) voted that nanoscale ingredients should be banned from food in the European Union (EU) until the health and environmental risks they might pose are better understood, and that any nanoscale ingredients that are eventually authorized should be clearly labeled as such. The EP voted on several amendments to draft legislation concerning the authorization of novel foods, including a provision that would prohibit food from cloned animals or their offspring. The EP has been unable to reach agreement with the European Council on the legislation, largely because of the provision concerning cloned animals. The Council also disagrees that foods containing nanoscale ingredients should be systematically labeled, however. According to an EP spokesperson, the legislation likely will go to conciliation, during which the EP and European Council will attempt to negotiate a compromise after two readings have failed to produce an agreement. The legislation likely will be discussed again in the fall.

On July 2, 2010, the European Commission’s (EC) Joint Research Centre (JRC) announced the availability of a reference report entitled Considerations on a Definition of Nanomaterial for Regulatory Purposes. JRC prepared the report in response to a request from the European Parliament (EP). JRC states that the aim of the report is to review and discuss issues and challenges related to a definition of “nanomaterial,” and to provide practical guidance for a definition for regulatory purposes. JRC suggests that a definition for regulatory purposes should:

Only concern particulate nanomaterials;

Be broadly applicable in European Union (EU) legislation, and in line with other approaches worldwide; and

Use size as the only defining property.

JRC states that this calls both for a clarification of the meaning of the word “material” and a clear definition of the nanoscale limits. Enforceability of the definition will require the adoption of instructions on how such limits can be applied for nanoscale materials with size distributions. Size-derived properties, nanoscale materials incorporated in a matrix, and the origin of the material are also points that should be considered. JRC states: “It is clear that any definition will have implications within the context in which it is used and may need adaptation for specific regulations or directives. It should therefore be emphasised that adoption of a definition will also involve policy choices, and accordingly will entail political decisions.”

On June 6, 2010, the European Commission (EC) Joint Research Center Institute for Health and Consumer Protection (JRC-IHCP) and the Chinese Academy of Inspection and Quarantine signed a Memorandum of Understanding (MOU) at the European Union (EU)-China Food Safety Scientific Seminar held at the Shanghai World Expo. According to JRC-IHCP, “[b]oth institutions provide technical support for policy makers and aim to reinforce their co-operation in scientific research for consumer products safety.” The MOU is intended to support risk management, and, through new approaches in nanotechnology, to improve consumer protection. JRC-IHCP cites the globalization of markets as one reason for this joint effort, saying “food safety or consumer protection are no longer domestic issues, but need to be addressed in an international collaboration.”

On May 4, 2010, the European Parliament (EP) Committee on the Environment, Public Health, and Food Safety voted on draft legislation regarding “novel foods,” which are defined as those that have not been consumed to a significant degree in the European Union (EU) before May 1997. Under the legislation, foods produced by nanotechnology processes would be required to undergo risk assessment before being approved for use, and approved products would be subject to labeling requirements. According to the Committee, foods produced by nanotechnology processes must remain excluded from the European Community (EC) list until they have undergone specific and adequate risk assessments, and the possible health effects of materials at nanoscale are better understood. The draft legislation would define nanomaterials as having one or more dimensions less than 100 nanometers (nm). All ingredients present in nano-form would need to be clearly indicated in the list of ingredients. The EP plenary vote on the draft legislation is scheduled for July 2010.

On March 16, 2010, the EP Environment Committee approved draft legislation intended to modernize, simplify, and clarify food labeling within the EU. The legislation would make minor changes to existing rules on required labeling information, such as name, list of ingredients, “best before” or “use by” date, specific conditions of use, and add a requirement to list key nutritional information. The Committee added that showing the country of origin should also be mandatory in some cases. According to EP, the Committee “demand[s] that products containing nano-materials, be clearly labelled as such, using the epithet ‘nano’ in the ingredient list.” To provide industry time to meet the new requirements, the regulation would enter into force 20 days after its publication in the EU Official Journal, but the rules on nutrition labeling would take effect three years thereafter. For food business operators with fewer than 100 employees and an annual turnover and/or annual balance sheet total under €5 million, the rules would take effect five years thereafter. EP plans its first reading of the proposed legislation in plenary session at the end of May 2010. The Council will then have to adopt its position, before the proposal is again debated in the EP Environment Committee.

On January 8, 2010, the United Kingdom (UK) House of Lords Science and Technology Committee announced the availability of its report entitled Nanotechnologies and Food, which criticizes the food industry for failing to be transparent about its research into the uses of nanotechnologies and nanomaterials. In its report, the Committee urges the Government and Research Councils to fund research into potential health and safety risks arising from the use of nanomaterials in the food sector. The Committee recommends that the Food Standards Agency maintain a publicly available register of food and food packaging containing nanomaterials, and suggests that the register be made available online. The Committee calls for nanomaterials to be defined clearly in food legislation to ensure that all uses of nanomaterials in food are subject to appropriate risk assessment procedures. According to the Committee, regulatory definitions should use a change in functionality, i.e. how a substance interacts with the body, as the criterion that distinguishes a nanomaterial from its larger form, to ensure that any nano-sized materials with novel properties are included. The Committee also recommends that the UK work with other European Union (EU) nations to clarify what is meant by the phrase “properties that are characteristic to the nanoscale” in the draft definition proposed for the revised Novel Foods Regulation, by the inclusion in legislation of a more detailed list of what these properties comprise. The Committee also raises concerns about the potential for the illegal importation of food products containing nanomaterials not approved for use in food in the EU.

In an October 9, 2009, speech at the stakeholder conference concerning nanomaterials on the market, Stavros Dimas, European Commissioner for the Environment, stated that the European Commission (EC) “will review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental, or safety impacts over their life cycle.” The EC’s review is in response to an April 24, 2009, resolution adopted by the European Parliament that questions whether current legislation covers the relevant risks relating to nanomaterials and asks the EC to consider whether revisions are necessary to address nanomaterials. Dimas stated that the EC “has not made up its mind on how precisely to get the information needed.” The EC intends to look at measures taken by member states and non-European Union (EU) countries, including voluntary reporting programs.

Dimas examined whether the existing regulatory framework of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program is sufficient to ensure “a high level of protection of health, safety and the environment” from nanotechnology products. Dimas stated that nanomaterials are covered by REACH under the definition of a chemical substance, and the general obligations therefore apply as for any other substance. According to Dimas, the “important” question to ask is whether the one tonne threshold used by REACH is appropriate for nanomaterials. Dimas stated:

Once we have a better idea of the scope and nature of nanomaterials on the European market we can then take a step back and go through the rules. We will need to consider whether registration of the majority of nanomaterials will take place in 2010 or only at the end of the registration timetable in 2018 and if there are some nanomaterials that will not be registered under REACH. We will also need to look at other key provisions in REACH to see if they are adequate for nanomaterials.

The London School of Economics (LSE), Chatham House, the Environmental Law Institute (ELI), and the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars held a conference on September 10-11, 2009, on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies,” in London. LSE, Chatham House, ELI, and PEN are participating in an international collaborative project, Regulating Nanotechnologies in the EU and U.S., which is funded by a grant from the European Commission. Their research findings on issues of transatlantic regulatory cooperation were published in a report during the conference. The conference was intended to bring together regulatory experts from the United States (U.S.) and European Union (EU) to discuss recommendations from this research effort and to generate and examine new ideas that would enable greater transatlantic cooperation and convergence on nanotechnology oversight today and in the future. The materials released at the conference include a briefing paper entitled Regulating Nanomaterials:A Transatlantic Agenda, and the report entitled Securing the Promise of Nanotechnologies:Towards Transatlantic Regulatory Cooperation.

Lynn L. Bergeson moderated a panel concerning chemicals regulation and nanomaterials, and Steve Owens, Assistant Administrator for Prevention, Pesticides, and Toxic Substances, U.S. Environmental Protection Agency (EPA), was one of the panelists. According to Owens, EPA is considering proposing new reporting requirements for manufacturers of nanomaterials. Owens described the Nanoscale Materials Stewardship Program, which EPA intended to encourage submission and development of information, including risk management practices for nanoscale materials, “less than a resounding success.” The reporting requirements would help EPA collect more environmental, health, and safety data regarding nanomaterials.

The European Agency for Safety and Health at Work (EU-OSHA) announced June 19, 2009, the publication of the Literature Review -- Workplace Exposure to Nanoparticles, which reviews the most recent publications on nanoparticles and focuses on the possible adverse health effects of workplace exposure. The report focuses on the possible adverse health effects of workplace exposure to engineered nanomaterials and possible subsequent activities taken to manage the risk. The report does not include nanomaterials originating from natural sources, as well as non-intended nanoscale by-products, such as diesel engine exhaust, and welding fumes. To provide a broad overview, EU-OSHA collected information from different sources, such as scientific literature, policy documents, legislation, and work programs. EU-OSHA gave priority to documents from the European Union (EU), although national and international activities are also described. The report considers studies published up to November 2008. The report identifies the following topics as priorities for future actions and activities:

Identification of nanomaterials and description of exposure;

Measurement of exposures to nanomaterials and efficacy of protective measures;

Risk assessment of nanomaterials in line with the current statutory framework;

In vivo studies for assessment of the health effects of nanomaterials;

Validation of the in vitro methods and methods of physico-chemical properties as methods to determine health effects; and

Training of workers and practical handling guidelines for activities involving nanomaterials in the workplace.

On May 28, 2009, during the Helsinki Chemicals Forum organized by the European Commission (EC) and European Chemicals Agency (ECHA), governmental spokespersons said that the way the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program applies to nanoscale substances is being reconsidered. ECHA Executive Director Geert Dancet stated that specific regulation of nanomaterials could be considered when the EC reviews REACH, which it is required to do by June 1, 2012. According to Dancet, the review could cover both the scope and implementation of REACH. Dancet stated that “nanomaterials will be covered in a more systematic way” following the review. European Union (EU) Environment Commissioner Stavros Dimas stated that “further work needs to be done to consider if further legislation is needed” to regulate nanomaterials. After the Forum, Dimas stated that separate legislation could be necessary to ensure to protect the environment and human health. According to Dimas, ECHA could manage nanomaterials, or EU legislation concerning fine particles could be used to regulate nanomaterials. The fine particle legislation concerns particles in air rather than in products, however, and a spokesperson for Dimas stated that the EC is “looking at all sorts of possibilities” and that specific approaches are “unexplored as yet.”

During the June 29-July 1, 2009, meeting of the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Substances (GHS), the Committee will discuss a paper entitled “Ongoing Work on the Safety of Nanomaterials.” The paper provides a summary of current activities by the European Union (EU), including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, International Organization for Standardization (ISO), and the Organization for Economic Cooperation and Development (OECD). The paper includes the following questions:

Can it be considered, for the same chemical (same [Chemical Abstracts Service (CAS) Number] and purity) that nanomaterials with new properties have the same hazards as conventional form?

Is it possible to distinguish for a same chemical, the properties of its different nanoforms?

How can this be done? Should new endpoints be determined?

To which extent information about nanomaterials need be provided?

What kind of information is needed?

What kind of communication tool is needed for this purpose?

What kind of collaboration can be suggested in order to contribute to clarification of nanomaterials hazard classification and indeed to heath safety and environmental issues of nanomaterials?

The European Commission (EC) will hold a scientific hearing on nanotechnology on September 10, 2009. The hearing will focus on the scientific aspects of the issues covered in the nanotechnology opinions issued by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Scientific Committee on Consumer Products (SCCP) (which is now replaced by the Scientific Committee on Consumer Safety (SCCS)). To prepare for the hearing, the EC is launching a public consultation relating to the three main objectives to be addressed:

Identification of any possible topics which have not been covered in the opinions from the relevant European Union (EU) risk assessment committees and bodies;

Identification of what are -- according to current scientific knowledge -- the main potential risks that could emerge from the use of nanomaterials in the future; and

Identification of the issues to be discussed at the hearing, including provision of background information and comments on those issues.

The outcome of the consultation will be presented at the scientific hearing. Comments are due June 19, 2009.

On March 24, 2009, the European Parliament (EP) approved an update of European Union (EU) legislation on cosmetics. The new regulation is intended to remove legal uncertainties and inconsistencies, while increasing the safety of cosmetics. The regulation would replace 27 different regulations. The new regulation addresses nanomaterials used as cosmetics ingredients. As requested by the EP, the new regulation introduces a safety assessment procedure for all products containing nanomaterials, which could lead to a ban on a substance if there is a risk to human health. The EP also succeeded in requiring that any nanomaterials present in cosmetics be mentioned in the list of ingredients on the packaging. The new regulation also includes a definition of nanomaterials, which must be adapted by the European Commission (EC) in line with scientific and technological advances. Under the new regulation, nanomaterial would be defined as “an insoluble or bioresistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”

On October 8, 2008, the European Commission (EC) published a regulation amending the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Annex IV to remove carbon and graphite. Although the substances were originally listed in Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties, a European Union (EU) expert committee delisted the substances in June 2008. According to the regulation, there is insufficient information for carbon and graphite to be listed in Annex IV, “in particular due to the fact that the concerned EINECS and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in this Annex.”

On June 17, 2008, the European Commission (EC) issued a press release entitled “Commission starts public dialogue on nanotechnologies -- tapping economic and environmental potential through safe products.” According to the EC, while current European Union (EU) legislation “covers in principle” the environment, health, and safety issues concerning nanomaterials, “there is further need for research and international cooperation.” EC will begin a consultation with stakeholders and member states that it intends “to increase knowledge and awareness about the potential of nanotechnologies and to continue to ensure an adequate protection of nature, environment and health.” Under “Next Steps,” the EC states:

Knowledge about the characterisation of nanomaterials, hazard and exposure needs to be improved. The Commission is therefore backing targeted actions in a number of areas and at different levels, particularly in the field of research and development under the Research Framework Programmes FP6 and FP7 and the Commission’s Joint Research Centre.) Such activities are coordinated and discussed with stakeholders and in the framework of the [Organization for Economic Cooperation and Development (OECD)] and the International Standardisation Organisation (ISO) and through international cooperation.

The Commission will also engage in an open dialogue with citizens and stakeholders at large to accompany the correct application of existing legislation to the new products arriving on the market.

In a January 28, 2008, report entitled EU Nanotechnology R&D in the Field of Health and Environmental Impact of Nanoparticles, the European Commission (EC) provides an overview of past and ongoing research projects funded by the Framework Programmes (FP), EU member states, candidate countries, and countries associated to FP6 or FP7 in the area of possible impacts in health, environment, and safety of nanoparticles. The report has information on 106 projects, 14 of which are from the FPs, which provide around 32 million € in grants. The other 92 projects are from the EU members states, which spent around 47 million € in grants. The EC states that the “information may well be incomplete” and asks all interested parties to send additional information on research projects funded through national funding schemes. The EC intends to update the information regularly.

According to a report recently released by the Danish Ministry of Health and Prevention, nanotechnology research, development, and applications are covered by existing legislation. The report, which includes an English summary, reviews existing national and international legislation in the areas of foods, medicines, the environment, chemicals, and the working environment in relation to current knowledge of nanotechnological products and processes. The report also includes a chapter on national and international research policy activities, and describes the initiatives, working groups, and network groups the relevant government departments are taking part in, both nationally and internationally. The working group that prepared the report included representatives from the Ministry of the Interior and Health, the Danish Board of Health, the Danish Environmental Protection Agency, the Danish Medicines Agency, the Danish Veterinary and Food Administration, the National Food Institute at the Technical University of Denmark, the Danish Agency for Science, Technology, and Innovation, the Danish Working Environment Authority, and Danish Standards.

The General Summary states:

It is the opinion of the working group that research, development and application of nanotechnology are covered by existing legislation. In view of this, the working party does not consider there to be a need for special nano-legislation.

However, the working group also considers that there will continue to be a need, determined by future development, to assess and if necessary adapt rules and executive orders etc. within the framework of existing legislation. Work is in progress in a number of national and international forums to create the necessary conditions for such adaptation, in part by establishing standards and limit values.

The [European Union (EU)] and the [Organization for Economic Cooperation and Development (OECD)] are playing a key role in connection with risk assessment of nanotechnology, in part through the EU’s [Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and Scientific Committee on Consumer Products (SCCP)]. It is therefore important to keep an eye out for recommendations and assessments issued by the EU and the OECD, as it will be possible to use these actively in connection with the adjustment of Danish rules and executive orders.

On 3 January 2008, Lloyd’s released a report entitled Nanotechnology: Recent Developments, Risks and Opportunities, which examines the potential risks and opportunities in the emerging field of nanotechnology. Lloyd’s states that nanotechnology “promises to improve many industries including medicine, food technology, textiles, materials, cosmetics, defence and more, but the risks are still not fully understood.”

The potential risks and opportunities, according to Lloyd’s, include:

A Potentially Large Market: One estimate by the Lux Research says that 15% (by value) of all products will contain nanotechnology by 2014. Currently most nanotechnology products are found in the sports, household and food industry, though others are using them to a growing extent. This is a rapidly growing and potentially large future market.

Nanoparticles, Different Material Properties: Nanoparticles can be much more reactive than larger volumes of the same substance. Such particles often have unknown toxicity which can be difficult to quantify. They can disperse easily in air or water. Researchers believe this form of nanotechnology is the most risky at present and the insurance industry should monitor developments in this field closely.

Unknown Impacts on Health: It is unclear whether nanoparticles can cause chronic health effects. Studies are still speculative, but insurers would be prudent to consider adverse scenarios when agreeing to terms and conditions, and when determining pricing and capital. In particular, whether a claims made trigger as opposed to an occurrence trigger is appropriate, and whether limits should have an aggregate limitation.

Unknown Impacts on the Environment: There is still too little research into the potential negative impacts of this technology on the environment. Given the large pollution losses faced by the insurance industry in the past, this is cause for concern although there are now many exclusions in place to limit such losses. As for health impacts, where there is cover, insurers may want to consider the terms and conditions carefully and whether to exclude losses due to the reduction of property values.

Many Positive Effects: Nanotechnology could also bring direct benefits to risk mitigation in the form of new materials that are stronger or more adaptive than before. Cars could be made to absorb more of the impact during a crash; building materials could be made stronger and more flexible to resist damage from earthquakes, fire, flood, and corrosion. Environmental clean-up operations could be made easier and cheaper with the use of specialised nanoparticles. Medicine could be transformed by nanotechnology, allowing cheaper and more sensitive diagnostic tools for diseases, giving insurance professionals better statistics to determine pricing. Because the benefits are so “seductive,” however, society may rush to capitalise on them before adequately assessing safety. The insurance industry must ensure that its own financial health is not compromised by systemic aggregations of loss from these technologies.

Lack of Regulation: Currently almost all regulation of nanotechnology is done using existing mechanisms. The “wait and see” approach is increasingly becoming a dangerous way to determine the risks. There is progress in this area, and the Organization for Economic Cooperation and Development (OECD) has released a “Nano Risk Framework,” which provides a framework for risk managers to address this. The precautionary principle is now accepted to apply to the degradation of human health as well as the environment, and suggests the use of this technology should be risk assessed appropriately before consumption by the public. This approach is being recommended within the European Union (EU), though the U.S. and Japan “prefer a lighter regulatory touch.” In the past, a vacuum of regulation has proved unhelpful to insurers. The insurance industry should lobby for clarity in this area.

The Swedish Chemicals Agency (KemI) recently released a report entitled Nanotechnology -- Large Risks with Tiny Particles? Although the report is in Swedish, it includes a summary in English. According to the report, the rapid development of new fields of application and a lack of knowledge call for caution. The report states that companies are responsible for ensuring that human health and the environment are not damaged and that legislation needs to be extended to cover nanomaterials.

The report includes the following recommendations for government regulators:

The Swedish Governmental Agency for Innovation Systems (VINNOVA) should draw up a strategy for nanotechnology research and development, which includes knowledge about risks to human health and the environment;

Special research funds should be allocated for the Swedish Research Council for Environment, Agricultural Sciences, and Spatial Planning (Formas) for research about the health and environmental risks of nanomaterials;

KemI should follow developments in the area and propose measures whenever it is justified, and participate actively in the development of new or modified testing methods within the Organization for Economic Cooperation and Development (OECD) cooperative framework;

KemI should produce a deeper analysis of the use of nanomaterials in chemical products and articles, after consultation with the trade organizations concerned;

Instruct the governmental agencies concerned to review the need for complementing existing legislation; and

Arrange, in the context of Sweden’s European Union (EU) presidency in 2009, a workshop on how the health and environmental risks of nanotechnology should be addressed by legislation.

On August 30, 2007, Greenpeace International (Greenpeace) issued a report entitled Navigating REACH: An Activists’ Guide To Using and Improving the New EU Chemicals Legislation (Guide), which is intended to explain how the European Union’s (EU) Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation will work, what main issues are at stake, and how the law will be implemented. The Guide highlights provisions that non-governmental organizations (NGO) and citizens can use to promote safer chemicals and lead ultimately to better protection of human health and the environment from the adverse impact of hazardous chemicals. The Guide includes nanomaterials among the issues for NGOs:

Adding nanomaterials to the scope of the legislation: The NGOs will keep working to highlight the need to improve current legislation to control the risks and manage this rapidly expanding industrial sector. According to the Guide, one of the windows of opportunity is the review of the scope of the legislation, as well as the review of information requirements for substances between one and ten tonnes (both in 2012). The Guide states that “this may be too late to start gathering data and limiting exposure to the rapidly increasing quantities of manufactured nanomaterials,” however.

On August 8, 2007, the European Commission (EC) released the scientific opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the appropriateness of the risk assessment methodology in accordance with the European Union’s (EU) technical guidance documents for new and existing substances for assessing the risks of nanomaterials. SCENIHR concluded that modifications to the existing technical guidance documents are necessary because special characterization of nanomaterial properties, which potentially differ considerably from conventional chemicals, is needed. Furthermore, the toxicological behavior and effects on health and the environment need to be assessed properly. The opinion states that, due to the lack of common rules for the toxicology of nanomaterials, the risk assessment of nanomaterials should be done on a case-by-case basis. SCENIHR identified issues requiring improvements in the technical guidance and methodologies, and proposed a staged strategy for the risk assessment of nanomaterials. Special consideration is required for the assessment of the potential translocation of nanoparticles in humans and other species, and potential adverse effects, for example, within the cardiovascular system or following passage across the blood-brain barrier.

On May 10, 2007, the European Commission (EC) announced the availability of the results of its April 16, 2007, workshop on intellectual property rights (IPR) in nanotechnology. The objective of the workshop was to identify specific IPR issues for nanotechnology and to discuss possible consequences for patent offices, policy makers, patent consultants, and the research community. Ongoing academic and political discussions have identified many aspects, such as the costs of patenting and the accessibility of patents for small- and medium-sized enterprises (SME) or developing countries; the need for a transparent and clearly defined scope of patent protection; the implications of “nanopatent land grab” and “patent thickets”; “nanotech patent battles”; and “second nature” and “monopoly patent.” The discussions were aiming at possible actions specific for nanotechnology, i.e., the need for a better patent monitoring system of nanotechnology for patent application and examining, technology analysis, and policy advice purposes, the possible need for harmonization between the European Union (EU), the U.S., and Japan, the need for a new nanotechnology patent regime, the development of guidelines for the protection of IPR and models for consortium and licensing agreements, lessons for collaborative research projects, and other research collaborations.

On March 20, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Nanotechnology and Life Cycle Assessment: A Systems Approach to Nanotechnology and the Environment, which summarizes the results of the October 2-3, 2006, workshop organized by PEN and the European Commission on life cycle assessment (LCA). LCA is a cradle-to-grave analysis of how a material affects ecosystems and human health. According to the report, the purpose of the October 2-3, 2006, workshop was to determine whether existing LCA tools and methods are adequate to use on a new technology. The report provides an overview of LCA and nanotechnology, discusses the current state of the art, identifies current knowledge gaps that may prevent the proper application of LCA in this field, and offers recommendations on the application of LCA for assessing the potential environmental impacts of nanotechnology, nanomaterials, and nanoproducts.

The report offers the following main conclusions identified by the workshop participants:

There is no generic LCA of nanomaterials, just as there is no generic LCA of chemicals.

The International Organization for Standardization (ISO) framework for LCA (ISO 14040:2006) is fully suitable to nanomaterials and nanoproducts, even if data regarding the elementary flows and impacts might be uncertain and scarce. Since environmental impacts of nanoproducts can occur in any life cycle stage, all stages of the life cycle of nanoproducts should be assessed in an LCA study.

While the ISO 14040 framework is appropriate, a number of operational issues need to be addressed in more detail in the case of nanomaterials and nanoproducts. The main problem with LCA of nanomaterials and nanoproducts is the lack of data and understanding in certain areas.

While LCA brings major benefits and useful information, there are certain limits to its application and use, in particular with respect to the assessment of toxicity impacts and of large-scale impacts.

Within future research, major efforts are needed to assess fully potential risks and environmental impacts of nanoproducts and materials (not just those related to LCA).

There is a need for protocols and practical methodologies for toxicology studies, fate and transport studies, and scaling approaches.

International cooperation between Europe and the U.S., together with other partners, is needed to address these concerns.

Further research is needed to gather missing relevant data and to develop user-friendly eco-design screening tools, especially ones suitable for use by small and medium sized enterprises.

The report also offers specific recommendations in the following areas:

Case-studies/prioritizing efforts: With limited resources, a case-study research approach could be adopted to enhance significantly knowledge on environmental impacts of nanomaterials and nanoproducts.

LCA studies and presentations of results: Any LCA study on nanoproducts and nanomaterials most likely suffers from high uncertainty issues.

Approaches.

Actions from stakeholders: Different stakeholders/authorities can potentially support the application and use of LCA for nanoproducts and nanomaterials through a large set of actions.